Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2026-01-06 @ 6:40 AM
Study NCT ID:
NCT07209761
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Organization:
Study Overview
Official Title:
A Phase 3, Randomized, Open-label, Multicenter Trial to Evaluate the Efficacy, Safety, and Tolerability of 4-month and 6-month Quabodepistat-containing Regimens for Rifampicin-resistant/Multidrug-resistant Pulmonary Tuberculosis
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QUANTUM-TB
Brief Summary:
This study aims to assess quabodepistat-based treatment regimens for RR/MDR-TB. The study will enroll adults and adolescents with rifampicin-resistant or multidrug-resistant pulmonary TB. The main goal is to see if a new drug called quabodepistat, when combined with other TB drugs, can shorten treatment duration to 4 months and be as effective and safer than current WHO endorsed treatment regimen given for 6-months. The study will compare different drug combinations in two groups of patients: those whose TB is sensitive to fluoroquinolones and those whose TB is resistant to fluoroquinolones. Participants will be randomly assigned to receive either the new treatment or the standard treatment. The study will last for 16 months for each participant and will measure how well the treatments work and how safe they are.
Detailed Description:
This is a Phase 3, randomized, open-label, multicenter trial evaluating quabodepistat-containing regimens for rifampicin-resistant/multidrug-resistant (RR/MDR) pulmonary tuberculosis (TB).
The study aims to enroll 532 participants aged 14 years and older.
The study has two main cohorts:
Fluoroquinolone-sensitive RR/MDR-TB (432 participants):
* Experimental arm: BPaQM (bedaquiline, pretomanid, quabodepistat, moxifloxacin) for 4 months
* Control arm: BPaLM (bedaquiline, pretomanid, linezolid, moxifloxacin) for 6 months
Fluoroquinolone-resistant RR/MDR-TB (100 participants):
* Experimental arm: BPaQ (bedaquiline, pretomanid, quabodepistat) for 6 months
* Control arm: BPaL (bedaquiline, pretomanid, linezolid) for 6 months
The primary efficacy endpoint is an unfavorable outcome by 12 months post-randomization.
Secondary endpoints include time to unfavorable outcome, time to sputum culture conversion, and safety/tolerability assessments. Participants will be followed for 16 months post-randomization.
The study will be conducted at approximately 40 sites in up to 12 countries.
An independent Data Monitoring Committee and Endpoint Adjudication Committee will be used in the study.
The trial aims to evaluate if quabodepistat-containing regimens can shorten treatment duration to 4 months for fluoroquinolone-sensitive RR/MDR-TB and provide a safer alternative to linezolid-containing regimens for both fluoroquinolone-sensitive and fluoroquinolone-resistant RR/MDR-TB.
The study aims to enroll 532 participants aged 14 years and older.
The study has two main cohorts:
Fluoroquinolone-sensitive RR/MDR-TB (432 participants):
* Experimental arm: BPaQM (bedaquiline, pretomanid, quabodepistat, moxifloxacin) for 4 months
* Control arm: BPaLM (bedaquiline, pretomanid, linezolid, moxifloxacin) for 6 months
Fluoroquinolone-resistant RR/MDR-TB (100 participants):
* Experimental arm: BPaQ (bedaquiline, pretomanid, quabodepistat) for 6 months
* Control arm: BPaL (bedaquiline, pretomanid, linezolid) for 6 months
The primary efficacy endpoint is an unfavorable outcome by 12 months post-randomization.
Secondary endpoints include time to unfavorable outcome, time to sputum culture conversion, and safety/tolerability assessments. Participants will be followed for 16 months post-randomization.
The study will be conducted at approximately 40 sites in up to 12 countries.
An independent Data Monitoring Committee and Endpoint Adjudication Committee will be used in the study.
The trial aims to evaluate if quabodepistat-containing regimens can shorten treatment duration to 4 months for fluoroquinolone-sensitive RR/MDR-TB and provide a safer alternative to linezolid-containing regimens for both fluoroquinolone-sensitive and fluoroquinolone-resistant RR/MDR-TB.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: